CRYSTALENS AND TRULIGN TORIC POSTERIOR CHAMBER INTRAOCULAR LENS
FDA premarket approval P030002/S037 · decided 2016-02-09
Approval details
- PMA number
- P030002
- Supplement
- S037
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Trade name
- CRYSTALENS AND TRULIGN TORIC POSTERIOR CHAMBER INTRAOCULAR LENS
- Generic name
- LENS, INTRAOCULAR, TORIC OPTICS
- Applicant
- Bausch & Lomb, Inc.
- Date received
- 2015-12-18
- Decision date
- 2016-02-09
- Days to decision
- 53 days
- Decision code
- APPR
- Product code
- MJP
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- Approval of the following changes to the post-approval study for the device: administrative changes, including changes to personnel and organization and changes to the informed consent form.
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